Transplant Evaluation
After reviewing the screening applications and test results, eligible patients are invited to an islet transplant orientation. This orientation provides an opportunity to learn more about the islet transplant and the studies being conducted at Emory. A member of the Islet Transplant Team will explain the evaluation process, the transplant process, and the testing and care that take place after the transplant. Patients are invited to bring a friend or family member to the orientation, questions are encouraged.
During the orientation the islet transplant “informed consent” is reviewed carefully. This consent is an important part of a clinical trial and provides the patient with detailed information about the study, including the risks and benefits. If the patient wishes to continue the evaluation process after the orientation, they are asked to sign the informed consent.
Step 1:
Patients deciding to sign the informed consent and proceed with evaluation are scheduled for consultation with an endocrinologist. This visit, and all others following, take place in the General Clinical Research Center (GCRC) at Emory University Hospital . The consultation will take approximately 2 hours.
At this appointment the patient submits a 30-day record of blood glucose levels, insulin dosages, and hypoglycemia episodes, along with a 24 hour urine specimen, specimens to test for blood in the stool, and tuberculosis (TB) skin test results. Specimens are collected for determining the blood group, urine albumin/creatinine ratio, comprehensive metabolic panel (blood chemistries), lipid profile (cholesterol), hemoglobin A1C and C-peptide (a determination of insulin production).
The endocrinologist completes a history and physical exam, and reviews the blood glucose records.
Step 2:
The islet transplant team reviews the information obtained during the consultation. If the patient continues to meet the criteria, they are asked to the first phase of evaluation. This evaluation takes about 8 hours and includes the following tests in different departments of the hospital.
- dobutamine stress echocardiogram (heart)
- electrocardiogram (heart)
- chest x-ray (lungs)
- abdominal ultrasound (liver)
- consultation with a transplant social worker
Blood is drawn for the following tests:
- Complete blood count (CBC)
- Toxicology (drug screen)
- Serological tests for Hepatitis B and C, HIV, HTLV, & Syphilis
- HLA antibody test (tissue type)
- Females: Pregnancy Test
Step 3:
The islet transplant team reviews the information obtained during the evaluation.
Eligible patients are asked to complete a second day of evaluation. The patient meets the transplant surgeon during this visit and has an opportunity to ask any further questions. Females receive a pregnancy test.
The following tests completed during this visit provide “baseline” data that can be compared to similar tests results completed after transplant.
- Arginine tolerance test
- IV glucose tolerance test
Step 4:
The patient is placed on the islet transplant waiting list and receives instructions.
All patients listed for transplant are provided with a FreeStyle™ glucose meter, which is used for all blood glucose testing during the study.
The patient is scheduled for the following tests, which must be completed before a transplant can be performed.
- retinal fundal photography
- continuous glucose monitoring, three days
What if I am not eligible for the study?
Applicants who do not meet the criteria for any of the current studies in islet transplant at Emory will be informed as soon as possible after that determination is made. All applications are kept on file and will be considered for future studies at Emory if the criteria for eligibility change. Applicants are encouraged to contact us at any time in the future to inquire about our progress and about current studies. Emory's endocrinologist will also be available to assist applicants and their doctor's with issues concerning management of diabetes.
